What is NDC 71610-063?

71610-063 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Carvedilol?

169 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carvedilol NDC 71610-063 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-063Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0063Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
71610-063-30	7161000633071610006330	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-30)Marketed from May 15, 2018
71610-063-53	7161000635371610006353	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-53)Marketed from May 15, 2018
71610-063-60	7161000636071610006360	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-60)Marketed from May 15, 2018
71610-063-80	7161000638071610006380	180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-063-80)Marketed from May 8, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Carvedilol
Generic name (nonproprietary): carvedilol
Active ingredients: Carvedilol — 6.25 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078384
Marketing start: Feb 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
Identifiers: Product ID 71610-063_dc72ac05-4435-4c84-ab22-2514e65b9fdeSPL ID dc72ac05-4435-4c84-ab22-2514e65b9fdeSPL set ID e3f463b5-2743-4a4a-a90a-bf1ee10a5458RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2
Pharmacologic class: alpha-Adrenergic Blocker; beta-Adrenergic Blocker

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471610006330 followed by a unit qualifier and the quantity

Package 71610-0063-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective May 29, 2018.

Indications (excerpt from the label)

Carvedilol Tablet is an alpha/beta-adrenergic blocking agent indicated for the treatment of: • Mild to severe chronic heart failure ( 1.1 ) • Left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) • Hypertension ( 1.3 ) 1.1 Heart Failure Carvedilol Tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Clinical Studies ( 14.1 )]. 1.2 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol Tablet is indicated to reduce cardiovascular …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-063

What is NDC 71610-063?: 71610-063 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Carvedilol.
What is the active ingredient?: Carvedilol.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carvedilol?: 169 other product NDCs are listed under this name. See all Carvedilol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Carvedilol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-690	72189-0690-90
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0973	67046-0973-03
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0879	67046-0879-03
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0336	67046-0336-03
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-664	72189-0664-60
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-663	72189-0663-90
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-653	72189-0653-90
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1616	67046-1616-03
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-501	72888-0501-0172888-0501-0272888-0501-03
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Advagen Pharma Limited	72888-499	72888-0499-0172888-0499-0272888-0499-03

All 170 Carvedilol NDCs

Other NDCs under ANDA 078384

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078384
Product	Strength	Form · route	Labeler	Product NDC
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-039
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-040
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-041
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-042
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-713
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-943
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1616
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-5275
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1407
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1457
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1813
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2474
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-062
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-066
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-067
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-653
Carvedilol	Carvedilol 3.125 mg/1	Tablet, Film coatedOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-110
Carvedilol	Carvedilol 6.25 mg/1	Tablet, Film coatedOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-111
Carvedilol	Carvedilol 12.5 mg/1	Tablet, Film coatedOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-112
Carvedilol	Carvedilol 25 mg/1	Tablet, Film coatedOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-113

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